View clinical trials related to Nasal Polyps.
Filter by:The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult participants with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39855 (POLYP 2; NCT03280537) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.
The purpose of this study is to determine the efficacy and safety of omalizumab compared with placebo in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have had an inadequate response to standard-of-care treatments. Study GA39688 (POLYP 1; NCT03280550) was another Phase III study by the Sponsor with identical objectives and design and was run in parallel with this study.
The purpose of this study is to compare the effects of Oxymetazoline and Epinephrine (which are 2 different nasal decongestants both of which are routinely used before sinus surgery) on blood loss and the surgeon's view of the surgical field during sinus surgery.
Nasal polyposis is a chronic inflammatory disease of the nose and sinuses. GlaxoSmithKline (GSK) is embarking on a clinical program to assess treatment of severe, recurrent nasal polyps with an anti-interleukin-5 (anti-IL5) (mepolizumab). Subject specific symptomatic endpoints will form the basis for the assessment of treatment benefit of nasal polyp therapies. However, there is a lack of published qualitative data regarding nasal polyps to understand the symptoms or health-related quality of life (HRQoL) impacts. This cross-sectional qualitative study aims to address this unmet gap by conducting semi-structured combined concept elicitation (CE) and cognitive debriefing (CD) telephone interviews and real-time data capture. The combined CE and CD interviews (each 90 minutes in duration) will investigate the subject experience of nasal polyps, and the relevance and understanding of existing patient-reported outcomes (PRO) instruments. The real-time data capture conducted over a 10 day period, will investigate the subject experience of the symptoms, HRQoL impacts and treatment of nasal polyps and any day-to-day variability that exists in these experiences in 'real time'. Twenty adult subjects in the United States (US), and 10 adult subjects in Germany with severe, recurrent nasal polyps will participate in the CE and CD interviews section of the study and of these, 10 subjects from US will also complete real-time data capture app task.
To detect the effect of hypertonic saline and fluticasone sprays on computed tomography scan of paranasal sinuses of patients having chronic sinusitis and/or nasal polyps.
Hippo-YAP pathway is a newly discovered pathway controlling the growth, and plays important roles in the regulation of stem cell function and tissue regeneration. Previously we found that a higher expression of YAP in NP, and LPS was able to activate the hippo-YAP pathway in NESCs. Thus, we hypothesize that the aberrant proliferation and differentiation of NESCs could be regulated via the hippo-YAP pathway.
Chronic rhinosinusitis (CRS) is a disease associated with impaired quality of life and substantial societal costs. Though sometimes co-appearing with other conditions, such as asthma, allergy, and nasal polyps, many cases present without co-morbidities. Micro-biological diagnostic procedures are frequently undertaken, but the results are often inconclusive. Nevertheless, antibiotics are usually prescribed, but invariably with limited and temporary success. Accordingly, there is a need for new treatments for CRS. Recent studies indicate that the sinuses are colonized by a commensal microbiome of bacteria and that damage to this natural microbiome, by pathogens or antibiotics, may cause an imbalance that may promote CRS. Therefore, treatments that restore the commensal microbiome may offer an alternative to current protocols. Arguably, as suggested by studies on patients with intestinal infections (next paragraph), one such possibility may be to transfer a "normal microbiome" to patients with CRS. A disrupted microbiome is linked to intestinal clostridium difficile infections. Probiotic restitution therapy may be effective even in cases recalcitrant to antibiotic treatment. However, a key to effective probiotic restitution is selecting the bacteria that facilitate regrowth of normal microbiome. As an answer to this, researchers have chosen to simply transplant the entire microbiome from a healthy donor. In the case of clostridium difficile infection in the form of faecal transplants. In this study, we will examine the possibility to treat patients with chronic rhinosinusitis without polyps (CRSsNP) with complete sinonasal microbiomes obtained from healthy donors. Our analysis will focus on symptoms and signs of disease as well as on nasal inflammatory and microbiological indices.
Verapamil is an L-type calcium channel blocker(CCB) which has been shown to reduce inflammation in a variety of tissues. Chronic rhinosinusitis with nasal polyps (CRSwNP) is characterized by eosinophilic inflammation as well as P-gp overexpression. A previous trial of oral Verapamil showed preliminary efficacy for the treatment of CRSwNP. The goal of this study is to evaluate the safety and efficacy of intranasal Verapamil in CRSwNP. The study was initially approved as a Phase Ib/II, but only the Phase Ib portion was completed as part of this protocol.
Nasal polyps (NP) has long been known as chronic inflammatory disease of the nasal mucosa. This disease is characterized by the presence of polyps in the upper nasal cavity, originating from within the ostiomeatal complex. The presence of polyps can cause long-term symptoms such as prominent nasal obstruction, post-nasal drip, loss of smell, and discharge. Mepolizumab (SB240563) is an Immunoglobulin G 1 [IgG1], kappa humanized monoclonal antibody (mAB) that blocks human interleukin-5 (hIL-5) from binding to the interleukin-5 (IL-5) receptor complex expressed on the eosinophil cell surface and thus inhibits signaling. Neutralization of IL-5 with mepolizumab has been shown to reduce blood, sputum and tissue eosinophils and hence is assumed to be a treatment option in a number of eosinophilic diseases including NP. The aim of this randomized, double-blind, parallel group, phase 3 (PhIII) study is to assess the clinical efficacy and safety of 100 milligram (mg) subcutaneous (SC) mepolizumab as an add on to maintenance treatment in adults with severe bilateral NP. The study will include a 4-week run in period followed by randomization to a 52-week treatment period. Participants will receive mepolizumab 100 mg or placebo SC by the investigator or delegate via a pre-filled safety syringe every 4 weeks for 52 weeks. Throughout the entire study period (run in + treatment period + follow up), participants will receive a standard of care (SoC) for NP which consists of daily mometasone furorate (MF) nasal spray, and if required, saline nasal douching, occasional short courses of high dose oral corticosteroids (OCS) and/or antibiotics. The treatment period will consist of thirteen, 4-weekly doses of mepolizumab or placebo. In addition, up to the first 200 randomized participants will be followed up every other month for up to a further 6 months after the Visit 15 (7 months post last dose) in order to assess maintenance of response and to validate a physiological model derived from the previous Phase 2 study. Approximately 400 participants will be randomized (200 participants per treatment arm) in to the study. Total duration of the study will be 76 weeks for first 200 randomized participants and 52 weeks for remainder of participants who are not participating in the 6 months no treatment follow up.
Chronic rhinosinusitis, also called chronic sinusitis, is a very common life-long disease affecting over 5% of the Canadian population. Its symptoms, including daily facial pain and headache, an inability to breath through the nose and complete smell loss, regularly impair one's ability to work and to enjoy and participate in daily activities. The annual cost of chronic sinusitis to Canada is estimated at $1.3 billion while the government pays an estimated $860 million yearly for chronic sinusitis treatment. Chronic sinusitis with polyps, the most common type of chronic sinusitis, is usually treated with a combination of medications and surgery. Until now, surgical treatment has only been performed in the operating room, at a cost of about $3500 per procedure. But, recent studies have shown that a new procedure, "in-clinic polyp removal", can provide an improvement in patient symptoms to levels equal to those for sinus surgery performed in a hospital operating room. Moreover, in clinic polyp removal has additional advantages including a shorter procedure recovery time, a significantly lower cost to the health care system (about one-tenth the cost or $450), and a shorter wait time for treatment. With the proposed pragmatic trial, the investigators will determine whether the in clinic polyp removal procedure is as good as sinus surgery in the operating room at controlling patient symptoms of chronic sinusitis. The investigators will also determine the cost and health-benefits for a patient, the healthcare system and for society of in clinic polyp removal in comparison to sinus surgery done in a hospital operating room. The investigators will then know if this new treatment, in clinic polyp removal, can replace sinus surgery as the standard of care for these patients.